NCT03618784

Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Kang Stem Biotech Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis

Detailed description

Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel, placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid arthritis

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	FURESTEM-RA Inj	The allogeneic umbilical cord blood-derived mesenchymal stem cells of each dose level as below were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension. Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump. * Dose level 1: 5.0 x 10\^7 cells /body 3 repeated intravenous injection at 4 week intervals * Dose level 2: 1.0 x 10\^8 cells /body 3 repeated intravenous injection at 4 week intervals
OTHER	sterile saline	sterile saline 3 repeated intravenous injection at 4 week intervals Placebo were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension. Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.

Timeline

• Start date: 2018-07-11
• Primary completion: 2021-10-05
• Completion: 2022-05-13
• First posted: 2018-08-07
• Last updated: 2022-10-10

Locations

7 sites across 1 country: South Korea